Development And Validation Of RP-HPLC Method For The Determination Of Lisinopril And Amlodipine In Bulk And Multicomponent Pharmaceutical Cardiovascular Dosage Form.

Main Article Content

Vijaykumar T. Pawar , Harinath N. More , Manish S. Bhatia


Objective: To develop a simple, accurate, linear, and precise RP-HPLC method for determination of Lisinopril and Amlodipine  in bulk and multicomponent pharmaceutical cardiovascular tablet dosage form and validate as per the ICH guidelines.

Methods: In the methods used Phenomenex Luna C18(2) (250 x 4.6 mm, 5 µ) column, mobile phase Methanol: 0.1 % Perchloric Acid (52.5: 47.5%, v/v), the flow rate of 1 ml/min and the detection wavelength of 220 nm using PDA detector.

Results: The calibration curves were linear r2 = 0.999 and 0.999 in the concentration range of 40 to 60 ug/ml for both Lisinopril and Amlodipine. The developed method resulted in elution of Lisinopril at 2.11 min and Amlodipine at 4.65 min. The % recovery was found to be 99.97%  to 100.09 % and 99.42% to 100.06% for Lisinopril and Amlodipine. The limit of detection was found to be 1.44 ug/ml and 2.62 ug/ml for Lisinopril and Amlodipine. The limit of Quantification was found to be 4.35 ug/ml and 7.94 ug/ml for Lisinopril and Amlodipine sequentially.

Conclusion: The present method of RP-HPLC was found to be accurate, simple and easy, specific, precise, linear, quick, and inexpensive. Within the concise analysis time, this method gives a superior resolution between both the compounds. That’s why the method to support good for the routine analysis of Lisinopril and Amlodipine in several pharmaceutical industries and also in academics.

Article Details